This week is one I have been working toward for a long time.
On Wednesday, we publish Frequency of Exclusion. A report built on data from 1,300 people who chose to share their lived experience with us.
There is a lot in this edition. Let's get into it.
Why Frequency of Exclusion exits.
I want to tell you something about Wednesday before the report lands. Not the findings. The reason it exists at all.
In 2020, during the first lockdown, I launched Demand Diversity. An awareness campaign about the lack of diversity in clinical trials. The world was already in a strange, frightened place. And then, five days after the first report landed, George Floyd was killed.
Everything shifted. The conversation about who gets seen, who gets heard, and who gets protected by systems that were supposed to serve everyone moved from a niche policy debate into something the whole world was sitting with. For a brief moment, the industry moved with it. Diversity and inclusion became a stated priority. Job titles were created. Commitments were made.
You know what happened next.
Those job titles are quietly disappearing. The language is being softened, reframed, or removed entirely. In the US, executive orders have made diversity and inclusion a phrase organisations actively avoid. In the UK, the retreat is less visible but it is happening. Across the industry, the people who were hired to do this work are being let go or repositioned, and the work is being absorbed back into functions that should never manage it.
Diversity and inclusion has become, in too many rooms, a dirty phrase.
I find that genuinely difficult. Not as a strategic concern. As something personal.
My father came to this country in the early seventies. He worked. He built something. He was let down by a healthcare system that didn't listen to him, didn't see him, and by the time it did it was too late. I was seventeen in that hospital room. I have spent twenty years trying to turn that experience into something that changes the outcome for someone else.
I am not going to stop doing that because the political climate has made it uncomfortable.
1300 people shared something personal with us. Their experience of healthcare. The moments where the system saw them and the moments where it didn't. The gap between what the system thinks their life looks like and what it actually looks like.
They did that because someone they trusted in their community said this was different. That the data wouldn't disappear into a report that gets filed. That it would be used to change something.
That trust is the most valuable thing we have built. And it is what I feel the weight of most acutely this week.
World Clinical Trials Day marks the moment in 1747 when James Lind conducted what is considered the first controlled clinical trial. What gets less attention is who gets included in the trials we run today, and who has been quietly designed out of them for decades.
Frequency of Exclusion is our answer to that question. Built from the ground up with the communities it is about. Not extracted from them. Built with them.
When the industry backs off, I lean forward. That is not a positioning statement. It is personal.
Wednesday. I hope you read it.
What we found: a teaser
1,200 people told us what actually stops them from taking part in clinical research. Not what researchers assumed would stop them. What actually does.
The single most common barrier in the entire dataset is not distrust. It is not fear of side effects. It is not lack of awareness.
It is too many hospital visits.
That is a design problem. The visit schedule is set by protocol teams who have never had to organise childcare, negotiate shift patterns, or work out how to get across a city without a car. And the communities who carry the highest disease burden are disproportionately the ones for whom that burden is unmanageable.
The second thing that came through clearly is that people are not disengaged from research. They are disengaged from the way research has treated them. Across the dataset, people described fearing being treated as test subjects rather than human beings. They described information so full of jargon it felt designed to confuse rather than inform. They described wanting to know what happened to their contribution after they gave it, and almost never finding out.
The most frequent combination of things that would make people more likely to participate? Remote options, a trusted messenger from their own community, and a clear plain-language explanation of what was involved. None of those are expensive. All of them require a decision to design differently.
And then there is the finding I want to sit with the longest. A small group in our data had genuinely positive experiences of clinical trials. They liked research in principle. They said they would take part again.
And they still reported being structurally blocked. Caring responsibilities. Work constraints. Transport.
These are not people who need persuading. They are people the system keeps failing despite their willingness. That is not an engagement failure. That is an infrastructure failure. And it is exactly what Frequency of Exclusion is built to name.
The full report lands Wednesday. An announcement email will come directly from me. If you know someone working in clinical development, protocol design, or patient strategy, send it to them that morning.
Frequency of Exclusion. Unwritten Health, 2026.
Announcing Now Written: Live
I've been building something else alongside the report.
For the last several months I've been having conversations that belong in public. With leaders who know exactly where the gaps are but can't say so in official channels. With clinical researchers who have spent careers trying to fix from the inside what needs fixing from the outside. With community advocates who have been saying the same things for twenty years and watching the industry nod along and change nothing.
Those conversations are becoming a series.
Now Written: Live. Every Wednesday at 2pm UK, 9am ET. Starting mid-June (Date TBC)
This is not a panel show. It is not a thought leadership slot. It is something simpler and more important than either of those things. It is the stories of people who have been underrepresented, unheard, and unseen by the systems that were supposed to serve them. Told in their own words.
At a moment when diversity and inclusion is being erased from the language of organisations that used to champion it, these stories need to be heard more, not less. That is why this series exists now. That is why it is called what it is called.
I will be announcing the first guest shortly. Follow me on LinkedIn to catch it when it lands.
Every Wednesday. 2pm UK. 9am ET. Mid-June.
What's moving in the regulatory landscape this week.
A few things worth knowing if you work in clinical development or patient strategy.
The UK's new clinical trials regulations are now live. From April 28, transparency is a statutory obligation, not a best-practice aspiration. Sponsors must register trials before first recruitment, publish results summaries within twelve months of completion, and offer participants a lay summary they can actually understand. Non-compliance is an offence. The Health Research Authority has already published performance data showing that only 32% of trials ending in 2023 published results on a public registry. That gap between the old expectation and the new legal requirement is where a lot of teams are currently exposed.
Separately, the EMA's reflection paper on patient experience data closed its consultation period in January. The direction of travel is clear: patient experience data is moving toward being submission-relevant, not supplementary. Teams that have been treating it as a goodwill gesture are going to find themselves behind.
And the framing coming out of conference commentary this week is worth noting. Representation is increasingly being positioned as a scientific validity question, not a DEI posture. That shift in language matters commercially. It is much harder to deprioritise in a budget conversation when it is framed as evidence quality rather than corporate responsibility.
Sources: Health Research Authority, 21 April 2026; European Medicines Agency.
Thanks for reading. This newsletter exists because I believe the right framing, in the right hands, changes decisions. If it did that for you this week, even a little, that's enough.
Ashish.